Direct message the job poster from Recruitment by Aphex
Recruitment Lead | C&Q | Validation | Quality | Life Sciences Talent Specialist
Purpose
The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following:
Responsibilities
* Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing comprehensive compliant documentation of all findings.
* Clear and concise technical writing of complex investigations
* Drive improvements to the investigation process
* Present investigations to regulatory inspectors and internal auditors
* Clearly communicate investigation progress to impacted areas and leadership
* Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
* Project management of the investigations end to end
* Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
* Build effective relationships across functions.
* Navigate through ambiguity and provide a structured problem-solving approach.
* Able to apply inductive and deductive reasoning in the investigation process
Qualifications
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR * Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
* Detailed technical understanding of fill/finish operations
Seniority level
* Associate
Employment type
* Contract
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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